Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 5, 7, 9-11, 13, 15-16, 18-20, 23, 25, 28, 30-31, 35, 38, 40, and 43) in the reply filed on 12/08/25 is acknowledged. Applicant’s note about claim 35 being included in Group I is acknowledged. The Examiner is including claim 35 in the prosecution of Group I claims.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 50-51 and 53-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-2, 5, 7, 9-11, 13, 15-16, 18-20, 23, 25, 28, 30-31, 35, 38, 40, and 43 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/07/23 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Claim Objections
Claims 1 and 28 are objected to because of the following informalities:
In claim 1, line 3, the article “a” should be added before the term “hemostatic.”
In claim 28, last line, the recitation of “2)” should be deleted.
Appropriate correction is required.
Notice for all US Patent Applications filed on or after March 16, 2013
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5, 7, 9-11, 13, 15-16, 18-20, 23, 25, 28, 30-31, 35, 38, 40, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Gannett et al. (US 2021/0052766 A1 – “Gannett”), in view of Guo et al. (RSC Adv., 2015, 5, 37377-37384 – “Guo”) and Jankun et al. (International Journal of Molecular Medicine 33: 367-372, 2014 – “Jankun”).
Instant claim 1 is drawn to a releasable iron-enhanced chitosan dressing comprising an iron-enhanced catechol modified chitosan, wherein the dressing is a hemostatic dressing.
Gannett teaches a biocompatible, foldable, thin profile, low mass and high surface area, chitosan dressing, optionally modified with catechol, and suitable for treating bleeding in a physiological environment, e.g. gastrointestinal (GI) tract (Title, Abstract, claims 1-57). The chitosan dressing is able to be released from the delivery device to allow withdrawal of the delivery device from the GI environment ([0026]). The dressing is a chitosan gastrointestinal hemostatic dressing (CGHD) and is amenable to use in all gastrointestinal bleeding applications and may be delivered by, for example, wire through a standard endoscopic working channel (≤3.2 mm diameter) or by balloon catheter delivery. The chitosan dressing comprises a catechol modified chitosan, is hemostatic and has a thickness that is 500 microns or less ([0011]). The dressing may have a dry dressing thickness that is one of: (i) about 200 microns or less; (ii) about 100 microns or less; or (iii) about 50 microns or less ([0011]). The dressing may have a density that is in an overlapping range of about 0.03 g/cm3 to about 0.7 g/cm3 ([0011]). “The dressing may have an adhesive side and a non-adhesive side. The dressing may have an adhesive side provided on a first layer and a non-adhesive side is provided on a second layer. The adhesive side of the dressing adheres to a tissue surface when the dressing is wet. The non-adhesive side of the dressing does not adhere to a delivery device when the dressing is wet. The dressing can adhere to a gastrointestinal mucosa in 1 minute or less … The dressing may comprise a porous surface wherein the porous surface provides one or more of: (i) and absorbent surface; and (ii) channels to redirect moisture away from a target tissue surface site. The dressing may adhere to wet tissue when in a wet condition. The dressing adherence strength may be greater than or equal to about 1 kPa. The dressing resists dissolution in water, saline solution, blood, or GI fluid at about 37°C for at least about 6 hours. The dressing can be folded or furled without cracking or tearing. The dressing may, in an open, unfurled, or unfolded condition, have an outward facing surface area that is one of about six times greater, about five times greater, or about four times greater than the outward facing surface area of that same dressing when it is in a closed, furled, or folded condition … The dressing can be punctured or sewn without cracking or tearing … The dressing is able to be delivered intact by a balloon device, a wire device, or an endoscopic device, wherein said device may comprise a working channel having a diameter of 3.2 mm or less, and wherein the dressing is delivered through the working channel …The dressing is able to wet and adhere intact to gastric mucosa in less than 30 seconds with application of light pressure … The dressing is able to resist dissolution for at least six hours after adhering to an injury site in presence of corrosive enzymes and acid environment of about pH 3 … The dressing is able to seal and protect a target tissue site for at least 12 hours …The dressing is able to achieve a controlled, slow dissolution from the attachment site over a period of time not exceeding seven (7) days … The dressing is not readily soluble in water, saline solution, blood, or GI fluid at about 37°C for at least 12 hours following application … The dressing does not does not increase or decrease in size by more than about 25% in length and width, or more than about 50% in thickness in the presence of water, saline solution, blood, or GI fluid at about 37°C … The dressing is capable of being terminally sterilized without affecting dressing characteristics. The chitosan dressing is capable of being stored under controlled conditions over time without affecting dressing characteristics ... ([0011]). The chitosan dressing can be applied to a mucus surface, e.g., in gastrointestinal tract by light pressure, which is a pressure at about most preferably 10 kPa or less (note 100 g/cm2 = 9.8 kPa) ([0042]). The dressing is able to stay in place intact and stop moderate to oozing bleeding, e.g., a bleeding rate of between about 20 ml/min to about 100 ml/min, or greater ([0026]). Foldability success can be rated as no tears or cracks being visible along the fold axis and no significant loss in tensile properties ([0062]). The dressing can be used for treatment of a disease, condition, disorder, trauma, or injury ([0012]). A delivery device is a minimally invasive device that can deliver the chitosan dressing to a physiological site in the body of an animal, wherein the delivery device is a balloon device ([0078]-[0079]). The chitosan dressing can be used to seal wound surfaces and slow or stop further bleeding ([0029], [0155], [0160]-[0161]).
Gannett does not expressly teach that the chitosan dressing comprises iron.
Guo teaches Fe3+-induced oxidation and coordination crosslinking in catechol-chitosan (CCS) hydrogels under acidic pH conditions (Title and Abstract). Guo teaches that the Fe3+-induced CCS hydrogel is essentially a dual cross-linking system composed of covalent and coordination crosslinks, under acidic pH conditions (Abstract). Fe3+-catechol interactions regulate many attributes of biological materials, such as toughness, extensibility and self-assembly (Abstract). The hydrogel formation was induced by Fe3+ and the formed hydrogel characterized (Page 37378 – sections 2.2, 2.3; Page 37379, sections 3.2, 3.3; Page 37382, section 3.7; Page 37383, section 4).
Jankun teaches that: “Iron extends clotting of plasma by interacting with proteins of the coagulation cascade and Fe3+ and/or its hydrolytic species interact with fibrinogen and/or fibrin changing their morphology and properties. … Iron plays a role in coagulation and can precipitate plasma proteins …” (Abstract). The addition of freshly prepared FeCl3 was manifested by an immediate increase of viscosity/precipitation of plasma proteins (Page 369, Col. 1, 1st full ¶). “In general FeCl3 weakens the fibrin clot while at the same time precipitating plasma proteins immediately after application. This property can be exploited therapeutically in stanching the flow of blood from wounds when optimum concentrations of FeCl3 are found” (Page 371, Col. 1, last ¶).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a releasable chitosan gastrointestinal hemostatic dressing modified with catechol, as taught by Gannett, in view of the Fe3+-induced oxidation and coordination crosslinking in catechol-chitosan (CCS) hydrogels wherein Fe3+-catechol interactions regulate many attributes of biological materials, such as toughness, extensibility and self-assembly, as taught by Guo, and the use of FeCl3 therapeutically in stanching the flow of blood from wounds, as taught by Jankun, and produce the instant invention.
One of ordinary skill in the art would have been motivated to include iron in the catechol modified chitosan dressing of Gannett because Guo teaches Fe3+-induced oxidation and coordination crosslinking in catechol-chitosan (CCS) hydrogels under acidic pH conditions (Title and Abstract) and Jankun teaches the advantage of including FeCl3 in stanching the flow of blood from wounds (Page 371, Col. 1, last ¶). One of ordinary skill in the art would have had a reasonable expectation of success in producing a functional hemostatic dressing by adding iron to the catechol modified chitosan dressing.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitations of a releasable iron-enhanced chitosan dressing, a catechol modified chitosan, and a hemostatic dressing would have been obvious over the chitosan dressing, optionally modified with catechol, and suitable for treating bleeding in a physiological environment, e.g. gastrointestinal tract (Title, Abstract, claims 1-57), wherein the chitosan dressing is able to be released from the delivery device to allow withdrawal of the delivery device from the GI environment ([0026]), as taught by Gannett. The limitation of iron-enhancement would have been obvious over the Fe3+-induced oxidation and coordination crosslinking in catechol-chitosan (CCS) hydrogels under acidic pH conditions (Title, Abstract, Page 37378 – sections 2.2, 2.3; Page 37379, sections 3.2, 3.3; Page 37382, section 3.7; Page 37383, section 4), as taught by Guo, and the addition of FeCl3 which was manifested by an immediate increase of viscosity/precipitation of plasma proteins (Page 369, Col. 1, 1st full ¶) and the use of FeCl3 in stanching the flow of blood from wounds (Page 371, Col. 1, last ¶), as taught by Jankun.
Regarding instant claim 2, the limitation of Fe III or ferric chloride (FeCl3) would have been obvious over the FeCl3 (Page 369, Col. 1, 1st full ¶ and Page 371, Col. 1, last ¶), as taught by Jankun.
Regarding instant claim 5, the limitation of the thickness of about 40-140 microns would have been obvious over the thickness that is about 100 microns or less; or about 50 microns or less ([0011]), as taught by Gannett.
Regarding instant claim 7, the limitation of the density of about 0.5 g/cm3 to about 1.1 g/cm3 would have been obvious over the density with an overlapping range of about 0.03 g/cm3 to about 0.7 g/cm3 ([0011]), as taught by Gannett. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claims 9 and 10, the limitations of an adhesive side, a non-adhesive side, and a porous surface would have been obvious over the adhesive side provided on a first layer and a non-adhesive side is provided on a second layer, and a porous surface ([0011]), as taught by Gannett.
Regarding instant claim 11, the limitation of the adhesive side adhering to a tissue surface when the dressing is wet and the non-adhesive side not adhering to a delivery device when the dressing is wet would have been obvious over the adhesive side of the dressing that adheres to a tissue surface when the dressing is wet and the non-adhesive side of the dressing that does not adhere to a delivery device when the dressing is wet ([0011]), as taught by Gannett.
Regarding instant claim 13, the limitation of adhering to a gastrointestinal (GI) mucosa in 1 minute or less would have been obvious over the dressing which can adhere to a gastrointestinal mucosa in 1 minute or less ([0011]), as taught by Gannett.
Regarding instant claim 15, the limitation of the porous surface providing (i) an absorbent surface; and (ii) channels to redirect moisture away from a target tissue surface site would have been obvious over the porous surface which provides one or more of: (i) and absorbent surface; and (ii) channels to redirect moisture away from a target tissue surface site ([0011]), as taught by Gannett.
Regarding instant claim 16, the limitation of the dressing adhering to tissue when the dressing is wet and wherein the dressing adherence strength is greater than or equal to about 1 kPa would have been obvious over the dressing which may adhere to wet tissue when in a wet condition, and the dressing adherence strength which may be greater than or equal to about 1 kPa ([0011]), as taught by Gannett.
Regarding instant claim 18, the limitation of the dressing that resists dissolution in water, saline solution, blood, or GI fluid at about 37°C for at least about 6 hours would have been obvious over the dressing which resists dissolution in water, saline solution, blood, or GI fluid at about 37°C for at least about 6 hours ([0011]), as taught by Gannett.
Regarding instant claim 19, the limitation of the dressing that can be folded, punctured, sewn, furled, or any combination thereof, without cracking or tearing would have been obvious over the dressing which can be punctured or sewn without cracking or tearing ([0011]), as taught by Gannett.
Regarding instant claim 20, the limitation of the dressing, when in an open configuration, the open configuration being, unfurled, or unfolded, having an outward facing surface area that is one to about six times greater, about five times greater, or about four times greater than the outward facing surface area of the dressing when in a closed configuration, the closed configuration being, furled, or condition would have been obvious over the dressing which in an open, unfurled, or unfolded condition, has an outward facing surface area that is one of about six times greater, about five times greater, or about four times greater than the outward facing surface area of that same dressing when it is in a closed, furled, or folded condition ([0011]), as taught by Gannett.
Regarding instant claim 23, the limitation of the dressing able to be delivered intact by a delivery device, the delivery device being selected from a balloon device, a wire device, and an endoscopic device, the delivery device including a working channel having a diameter of 3.8 mm or less, through which the dressing is delivered would have been obvious over the dressing which is able to be delivered intact by a balloon device, a wire device, or an endoscopic device, wherein said device may comprise a working channel having a diameter of 3.2 mm or less ([0011]), as taught by Gannett.
Regarding instant claim 25, the limitation of the dressing, when wet, being able to adhere intact to gastric mucosa in less than 30 seconds with application of light pressure of about 50 - 100 g/cm2 would have been obvious over the dressing which is able to wet and adhere intact to gastric mucosa in less than 30 seconds with application of light pressure ([0011]), wherein the light pressure is a pressure at about most preferably 10 kPa or less (note 100 g/cm2 = 9.8 kPa) ([0042]), as taught by Gannett.
Regarding instant claim 28, the limitation of the dressing able to stay in place intact and stop bleeding, the bleeding being from between about 1 g/min to about 30 g/min or about greater than about 5 g/min would have been obvious over the dressing which is able to stay in place intact and stop moderate to oozing bleeding, e.g., a bleeding rate of between about 20 ml/min to about 100 ml/min, or greater ([0026]), as taught by Gannett.
Regarding instant claim 30, the limitation of the dressing being able to resist dissolution for at least six hours after adhering to an injury site in presence of corrosive enzymes and acid environment of about pH 3, and wherein dissolution of the dressing does not exceed seven days would have been obvious over the dressing which is able to resist dissolution for at least six hours after adhering to an injury site in presence of corrosive enzymes and acid environment of about pH 3, and wherein dissolution of the dressing does not exceed seven days ([0011]), as taught by Gannett.
Regarding instant claim 31, the limitation of the dressing being able to seal and protect the target tissue surface site for a period of time of up to about 12 hours, or for a period of time from about 12 hours to about 96 hours would have been obvious over the dressing which is able to seal and protect a target tissue site for at least 12 hours, and achieve a controlled, slow dissolution from the attachment site over a period of time not exceeding seven (7) days ([0011]), as taught by Gannett.
Regarding instant claim 35, the limitation of the dressing that is not readily soluble in water, saline solution, blood, or GI fluid at about 37°C for at least 12 hours following application would have been obvious over the dressing which is not readily soluble in water, saline solution, blood, or GI fluid at about 37°C for at least 12 hours following application ([0011]), as taught by Gannett.
Regarding instant claim 38, the limitation of the dressing that does not increase or decrease in size by more than about 25% in length and width, or more than about 50% in thickness, when in the presence of water, saline solution, blood, or GI fluid at about 37°C would have been obvious over the dressing which does not does not increase or decrease in size by more than about 25% in length and width, or more than about 50% in thickness in the presence of water, saline solution, blood, or GI fluid at about 37°C ([0011]), as taught by Gannett.
Regarding instant claim 40, the limitation of the dressing which is capable of being terminally sterilized and stored under controlled conditions without affecting dressing characteristics, wherein tensile strength is a dressing characteristic would have been obvious over the dressing which is capable of being terminally sterilized without affecting dressing characteristics ([0011]), and no significant loss in tensile properties ([0062]), as taught by Gannett.
Regarding instant claim 43, the limitation of the dressing which is able to be used in the treatment of a disease, condition, disorder, trauma, or injury would have been obvious over the dressing which can be used for treatment of a disease, condition, disorder, trauma, or injury ([0012]), as taught by Gannett.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5, 7, 9-11, 13, 15-16, 18-20, 23, 25, 28, 30-31, 35, 38, 40, and 43 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 65-66 and 74-82 of copending Application No. 16/958,301 (the ‘301 Application) in view of Guo et al. (RSC Adv., 2015, 5, 37377-37384 – “Guo”) and Jankun et al. (International Journal of Molecular Medicine 33: 367-372, 2014 – “Jankun”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a releasable iron-enhanced chitosan dressing comprising an iron-enhanced catechol modified chitosan, wherein the dressing is a hemostatic dressing, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claims of the ‘301 Application don’t recite that the catechol modified chitosan dressing is iron-enhanced as recited in instant claim 1.
The teachings of Guo and Jankun are discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a releasable chitosan gastrointestinal hemostatic dressing modified with catechol, as recited in claims of the ‘301 Application, in view of the Fe3+-induced oxidation and coordination crosslinking in catechol-chitosan (CCS) hydrogels wherein Fe3+-catechol interactions regulate many attributes of biological materials, such as toughness, extensibility and self-assembly, as taught by Guo, and the use of FeCl3 therapeutically in stanching the flow of blood from wounds, as taught by Jankun, and produce the instant invention.
One of ordinary skill in the art would have been motivated to include iron in the catechol modified chitosan dressing of claims of the ‘301 Application because Guo teaches Fe3+-induced oxidation and coordination crosslinking in catechol-chitosan (CCS) hydrogels under acidic pH conditions (Title and Abstract) and Jankun teaches the advantage of including FeCl3 in stanching the flow of blood from wounds (Page 371, Col. 1, last ¶). One of ordinary skill in the art would have had a reasonable expectation of success in producing a functional hemostatic dressing by adding iron to the catechol modified chitosan dressing.
Therefore, instant claims are obvious over claims of the ‘301 Application in view of Guo and Jankun, and they are not patentably distinct over each other.
Please note that a Notice of Allowability for the ‘301 Application was mailed on 02/05/26. However, since the ‘301 Application has not yet been patented, this is a provisional obviousness-type double patenting rejection.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615